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Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

BACKGROUND: Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause. OBJECTIVE: The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women. STUDY DESIGN: T...

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Autores principales: Colau, Jean-Claude, Vincent, Stéphane, Marijnen, Philippe, Allaert, François-André
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3585763/
https://www.ncbi.nlm.nih.gov/pubmed/22852580
http://dx.doi.org/10.2165/11640240-000000000-00000
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author Colau, Jean-Claude
Vincent, Stéphane
Marijnen, Philippe
Allaert, François-André
author_facet Colau, Jean-Claude
Vincent, Stéphane
Marijnen, Philippe
Allaert, François-André
author_sort Colau, Jean-Claude
collection PubMed
description BACKGROUND: Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause. OBJECTIVE: The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women. STUDY DESIGN: This was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011. SETTING: The study was conducted in 35 active centers in France (gynecologists in private practice). PATIENTS: One hundred and eight menopausal women, ≥50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥5 hot flashes per day with a significant negative effect on the women’s professional and/or personal life. INTERVENTION: Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks. MAIN OUTCOME MEASURE: The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. RESULTS: One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. CONCLUSION: BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication. Trial registration number (EudraCT): 2009-016959–21.
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spelling pubmed-35857632013-03-07 Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Colau, Jean-Claude Vincent, Stéphane Marijnen, Philippe Allaert, François-André Drugs R D Original Research Article BACKGROUND: Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause. OBJECTIVE: The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women. STUDY DESIGN: This was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011. SETTING: The study was conducted in 35 active centers in France (gynecologists in private practice). PATIENTS: One hundred and eight menopausal women, ≥50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥5 hot flashes per day with a significant negative effect on the women’s professional and/or personal life. INTERVENTION: Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks. MAIN OUTCOME MEASURE: The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. RESULTS: One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. CONCLUSION: BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication. Trial registration number (EudraCT): 2009-016959–21. Springer International Publishing 2012-12-18 2012-09 /pmc/articles/PMC3585763/ /pubmed/22852580 http://dx.doi.org/10.2165/11640240-000000000-00000 Text en © Colau et al., publisher and licensee Springer International Publishing AG 2012
spellingShingle Original Research Article
Colau, Jean-Claude
Vincent, Stéphane
Marijnen, Philippe
Allaert, François-André
Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
title Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
title_full Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
title_fullStr Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
title_full_unstemmed Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
title_short Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
title_sort efficacy of a non-hormonal treatment, brn-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3585763/
https://www.ncbi.nlm.nih.gov/pubmed/22852580
http://dx.doi.org/10.2165/11640240-000000000-00000
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